Healthcare Industry News:  Acute Coronary Syndrome 

Biopharmaceuticals

 News Release - January 9, 2007

Anthera Receives IND Approval from FDA to Begin Phase 2 'IMPACTS' Trial With A-001 for Prevention of Acute Chest Syndrome in Patients with Sickle Cell Disease

SAN MATEO, Calif., Jan. 9 (HSMN NewsFeed) -- Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that the U.S. Food and Drug Administration has approved its Investigational New Drug (IND) application for use of its lead compound A-001 in hospitalized patients with sickle cell disease. The IMPACTS (Investigation of the Modulation of Phospholipase in Acute ChesT Syndrome) trial is a multi- center phase 2 clinical study aimed at preventing a severe respiratory complication of sickle cell disease, acute chest syndrome. Acute chest syndrome, a form of acute lung injury, is the leading cause of death in sickle cell disease patients. It commonly follows admission to the hospital for other reasons, especially an episode of bone pain (a prominent feature of sickle cell disease). Recent academic clinical studies have demonstrated that serum secretory phospholipase A2 (sPLA2) levels rise in advance of acute chest syndrome, and therefore help identify patients at-risk. This creates a unique opportunity for early intervention for a serious inflammatory lung disease with a potent inhibitor of sPLA2 such as A-001. Worldwide, nearly 200,000 suffer from some form of sickle cell disease. This genetic disorder accounts for an estimated 60,000 hospitalizations per year and significantly reduces life expectancy.

"Our first product may provide a breakthrough therapy for sickle cell patients at risk of developing this life-threatening complication," stated Robert Fishman, MD, FCCP, Senior Vice President, Pulmonary and Critical Care Products. "We have had a great deal of support from the sickle cell physician community and expect to begin patient recruitment for this clinical study shortly."

"The initiation of this clinical study follows an extensive body of research implicating sPLA2 both in lung injury, and in acute chest syndrome in particular," stated Lori Styles, MD, Director, Pediatric Sickle Cell Program, Children's Hospital and Research Center at Oakland. "The possibility of preventing progression to acute chest syndrome in at-risk patients has enormous clinical relevance."

IMPACTS is a double-blind, randomized, parallel group, placebo-controlled dose escalation study. It will enroll up to 75 hospitalized patients, ages 12 through adult, at 15-20 U.S. centers of excellence in sickle cell disease. Enrolled patients will be those at-risk for development of acute chest syndrome based on the combination of bone pain, fever, and an elevated serum sPLA2 concentration. The main efficacy endpoint is freedom from the development of acute chest syndrome.

Further information about this clinical trial, sickle cell disease, and acute chest syndrome can be found at www.IMPACTStrial.com

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a privately-held pharmaceutical development company committed to world-class development and commercialization of promising clinical products to address the unmet medical needs of patients with life-threatening chronic and acute inflammatory diseases. In 2006, Anthera acquired worldwide rights (except Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase (PLA2) family -- a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes‚ prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel‚ upstream steps in the inflammation cascade and have the potential to address a variety of diseases including: acute chest syndrome, acute lung injury, acute respiratory distress syndrome, atherosclerosis, Acute Coronary Syndrome, chronic obstructive pulmonary disease and psoriasis. In order to efficiently commercialize this platform, Anthera has brought together a proven management team with extensive experience in licensing, clinical research, development, and commercialization of anti-inflammatory products. For more information please visit www.anthera.com .


Source: Anthera Pharmaceuticals

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